There is a lot of interest amongst rosacea sufferers surrounding the possibility of some kind of systemic treatment that will offer better UV protection. Especially for those with severe triggers from sun exposure, treatments like Afamelanotide look promising.

The CEO and Director of Clinuvel, Dr Philippe Wolgen, was kind enough to answer some questions relating to their developments and any potential tie-in with rosacea. Thanks Dr. Wolgen for taking the time to help us understand what Clinuvel is up to and how that fits in with what we can find on the internet.

1. We have heard of Melanotan, what is that?

In the early eighties, ‘Melanotan’ was a trade name for a series of peptides developed as potential skin cancer preventatives at the University of Arizona. These names are no longer used by the University and related companies.

In more recent times, the term ‘Melanotan’ has been associated and used by online vendors selling illegal chemicals over the net, whereby these pirates falsely claim that they are selling clean hormonal drugs. These chemicals have never been tested, have not received regulatory approval anywhere in the world and are a health hazard to consumers buying them online. Most of these consumers believe that these chemicals are safe tanning alternatives.

On the other hand, pharmaceutical drugs developed under controlled conditions and which receive regulatory approval for testing are subject to strict regulations, including controls on how they are manufactured, their purity levels and ingredients, their methods of administration and close monitoring by medical experts. Chemicals sold online as ‘Melanotan’ undergo none of these tests, and the public is warned to refrain from these substances.

2. How about afamelanotide, where does that fit in?

Afamelanotide is an optimized synthetic peptide manufactured under supervision of a global manufacturer, which is authorized by the FDA and EMA to synthesize legitimate amino acids to peptides.

Clinuvel has the exclusive worldwide rights to develop afamelanotide and it has chosen to develop the drug as the world’s first ‘medicinal photoprotective’ – that is, a drug that provides endogenous (from within) skin protection from UV and light.

Clinuvel has refined this drug since its early development; refining both the active pharmaceutical ingredient’s method of manufacture and ingredients, as well creating a novel delivery system: a controlled-release dissolvable implant. The drug is now administered by physicians as a subcutaneous implant – roughly the size of a grain of rice – which disappears after days. The effect of the drug lasts two months.

We’ve identified the most severe UV and -light related skin disorders and have tested afamelanotide for the past 10 years in humans to measure its photoprotective effect. Not only have we seen clinical response in these patients, more important is that we have seen a very safe profile in afamelanotide.

EPP is the lead indication, meaning where this drug is first used, and, we believe, the one for which patients have the greatest need for medicinal photoprotection.

3. There might be confusion surrounding some of the terminology people find on the internet. Please could you tell help us distinguish Epitan, Melanotan, Melanotan 2 and Afamelanotide?

Afamelanotide is the generic name of Clinuvel’s molecule and is not related to the chemicals sold today as ‘Melanotan’. Afamelanotide is a legitimate pharmaceutical ingredient being developed into a therapeutic product with a safe track record.

‘Melanotan’ and ‘Melanotan 2’ are self-injectable or inhalable chemicals and their names have been used by unscrupulous vendors online to sell chemicals of unknown origin purporting to have a cosmetic tanning effect or causing weightloss and libido enhancing. These are not pharmaceutical products: their manufacture, ingredients and use are unknown and their potential effects are unknown.

Nowhere in the world are products being sold online as ‘Melanotan’ or ‘Melanotan 2’ being tested in legitimate clinical trials; unfortunately those selling these chemicals are linking legitimate scientific research to their products in an attempt to legitimize their operations.

Epitan is a company that is no longer in existence.

4. Products seem to take years and years to become available. When might afamelanotide be available to doctors?

The approval and sale of drugs is regulated in every country or territory by a different regulatory agency (such as the FDA in the USA, EMA in Europe or TGA in Australia). Regulators review the history and development of a drug in depth once a final dossier of data is submitted by a sponsor company. The key regulatory review is whether a drug is safe and well tolerated by the patients for whom it is intended. Regulators then review the data to determine whether a drug is effective in preventing or treating the patients for whom it is intended and whether a drug is safe for human use. A drug is approved when a regulatory agency completes a review of the data presented by the sponsor and agrees that the effect of the drug in patients outweighs the possible risks or side effects posed by that drug. The process up until the regulatory review can take many years; the average time for a drug to reach the market from the lab is 10 years. Companies may spend an average of $US1billion getting drugs to market and, sadly, the vast majority of drugs fail well before they reach the market. It’s estimated that about one in every 10,000 molecules discovered in the lab will reach the market as a pharmaceutical product. Of every three drugs to reach Phase III (the last stage of clinical development), roughly two will fail.

Clinuvel is nearing the completion of its development program after more than a decade, and it is in this context that Clinuvel is developing a first-in-class drug, afamelanotide. We have taken a cautious and conservative approach by generating data preclinically and clinically, perhaps more than is strictly necessary to evaluate the safety of afamelanotide.

We are due to release full results from our first ever completed Phase III study before the end of March. Pending the results of this trial, we will make the decision of when to file a dossier for Marketing Authorisation with regulators. This will happen with European regulators first (a central procedure through the European Medicines Agency), followed by Switzerland, Australia and then the US. The timing is then dependant upon the regulatory process, which can take anywhere from 3-9 months. We’re posting overviews and discussion related to pharmaceutical development on our blog.

5. What are your thoughts about off-label usage of prescription products?

As a physician, I think off-label use is risky as most drugs have been tested in one disease only. The decision to prescribe the same drug for other diseases is often not founded on the testing data. A physician has certain autonomy, but the health of his patients should dominate his or her decisions. In this sense I am risk averse and conservative.

6. There are a number of individuals with rosacea who believe that afamelanotide may be an appropriate treatment for them; have you ever trialled the drug in rosacea?

We have not trialled afamelanotide in rosacea, so the drug’s effects are unknown.

7. Is there a possibility that afamelanotide may be effective in rosacea?

Unless a trial is conducted, it is impossible to speculate on the drug’s effects.

It is important to note, however, that a drug’s effects will vary from patient group to patient group; it is not wise to assume that what works in one indication will necessarily work in another.

8. Do you think your company might maintain an interest in the future with respect to rosacea?

For the moment we are focused on our chosen regulatory program

While we welcome the interest generated by individuals with rosacea, at present we are focused on completing our program in the other diseases.

9. Various `melanin enhancers’ (for want of a better term) seem to be available on the internet. What advice would you offer to those who are desperate or are interested in experimenting?

Consumers should note that there are currently NO prescriptive or pharmaceutically approved drugs to enhance pigmentation. Individuals should not use any product which has not been prescribed by a physician.

The internet phenomenon is a new challenge for the pharmaceutical industry, with consumers becoming gate keepers, but people need to be aware of the risks that these products can pose to their health.

10. Thanks for doing this Q&A, where can I find more information about Clinuvel?

Clinuvel also maintains an extensive resource library online on UV, light, skin and melanin which may be of interest to your readers.

Finally, as part of our ongoing commitment to quality online information, many of these networks will be upgraded in the coming months to help people better understand what the company does and the industry in which we work.

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4 Reader Comments

Philippe Wolgen is a bit sparing on the details and essentially deceptive in what he says relative to the history of this drug. Epitan was the company name that Clinuvel went by until 2006. Clinuvel (as Epitan) used the word ‘melanotan’ in their development of the now generic drug afamelanotide until 2005 (see: http://www.google.com/search?rls=en-us&q=site:clinuvel.com+%22melanotan+implant%22&ie=UTF-8&oe=UTF-8 ). The peptide sequence for afamelanotide is the same peptide sequence for melanotan-1. A rose by any other name is still a rose. There is nothing illegal in laboratories producing and selling melanotan-1 as a molecular substance. The patent for the melanotan-1 molecule expired in 2006. The primary illegal aspect of companies selling melanotan-1 is if they sell it specifically for human usage. For Clinuvel the only thing proprietary about the drug at this point lies in administration methods.

Wolgen is against off-label usage. That leaves a few thousand people he would prescribe this to.

Meanwhile millions of fair-skin people will just have to do without it unless they can somehow pay through the nose or find a doc to prescribe it off-label.

He also failed to mention how far the company has fallen behind on their prior announced plans of when the drug would be commercialized. A review of official announcements dating back to his 4 year tenure will uncover all that.

If they are so against people using Melanotan, maybe they can find a reasonable way for their drug to be accessible to others who need the increased melanin protection.

Palatin is developing a variant of Melanotan II called Bremelanotide. Again, a rose is a rose.

alpha-melanocyte stimulating hormone has shown very promising positive results in reducing systemic inflammation but the approach is to develop and approve the use for one disease or organ at a time. Currently renal failure is the flavor of the month. Check at NIH and Medline to see progress.

Although current methods of use range from subcutaneous injection & dissolvable solid implants to nasal sprays. Most interesting has been some research at gene transplantation (expression?) which appears to permanently bond that MSH gene to you.